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In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization
Sponsor: Incisive Technologies Pty Ltd
Summary
The goal of this clinical trial is to evaluate whether BlueCheck® can accurately detect and monitor early-stage dental caries (tooth decay) and their remineralization in adults. Participants will wear partial dentures with partially demineralized human enamel specimens. The main questions it aims to answer are: * Can BlueCheck® reliably detect early carious lesions with high sensitivity and specificity? * Does BlueCheck® visually reflect changes in remineralized enamel lesions? BlueCheck® results will be compared against standard diagnostic methods (e.g., Nyvad criteria, Diagnodent readings, surface microhardness) to see if BlueCheck® provides an objective, accurate, and visual method of detecting and monitoring early-stage caries. Participants will: * Wear a modified lower partial denture with four mounted enamel specimens for 28 days. * Use only the study-provided fluoride containing toothpaste * Attend weekly clinic visits for removal and laboratory analysis of one enamel specimen per week. * Undergo regular oral health checks and provide diary entries tracking brushing and any adverse events.
Official title: In Situ Clinical Trial Investigating the Ability of BlueCheck to Detect and Monitor Active Carious Lesions and Their Remineralization
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-09-24
Completion Date
2026-01
Last Updated
2026-01-20
Healthy Volunteers
Yes
Conditions
Interventions
BlueCheck
Caries Detection and Monitoring
Locations (1)
Oral Health Research Institute
Indianapolis, Indiana, United States